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Interwencja samobójcza dla młodzieży rdzennej Alaski (BeWeL)

22 października 2026 zaktualizowane przez: Elizabeth D'Amico, RAND

Porównawcza skuteczność dwóch skoncentrowanych na kulturze interwencji samobójczych dla młodzieży rdzennej Alaski

Two interventions will be delivered virtually to American Indian/Alaska Native youth who have been hospitalized with suicidal attempt, suicidal ideation, or associated risk behaviors, including alcohol-related injury.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

The investigators will conduct a randomized controlled trial whereby Alaska Native (AN) youth who are hospitalized for suicide risk will be randomly assigned to either Qungasvik/Tools for Life or Tools for Life + Motivational Interviewing Social Network (MISN) intervention after their baseline survey, and followed up at 3-, 6-, and 12 months. All youth will receive Tools for Life and two 30-minute virtual follow-up visits (at 2- and 6-weeks post intervention) focused on connectivity to culture and obtaining support from intergenerational social networks in their home communities. Half of the youth will also receive MISN in addition to Tools for Life. Both interventions will be delivered virtually by a wellness team comprised of Alaska Native community behavioral health aides, prevention specialists and/or Elders who function in their communities as natural healers.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

302

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

    • Alaska
      • Bethel, Alaska, Stany Zjednoczone, 99559
        • Yukon-Kuskokwim Health Corporation
      • Fairbanks, Alaska, Stany Zjednoczone, 99559
        • Tanana Chiefs Conference

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

14 lat do 24 lata (Dziecko, Dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Self-identify as Alaska Native youth
  • Between the ages of 14 and 24
  • Admitted to the hospital for suicide attempt, ideation, or associated risk behaviors including alcohol-related injury or acute intoxication

Exclusion Criteria:

-

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: Tools for Life

All youth will receive the Tools for Life (Qungasvik) intervention. Tools for Life is an evidence-based, community-developed intervention focused on providing protective cultural experiences for Alaska Native youth to address suicide risk and alcohol use.

Tools for Life focuses on empowering youth to learn more about their culture and their identity.

Aktywny komparator: Tools for Life + Motivational Interviewing Social Network intervention (MISN)

Half of the youth will will also receive MISN in addition to the Tools for Life intervention. MISN is an evidence-based treatment that augments motivational interviewing with personal social network composition and structure visualization as a means to cultivating healthy social networks and cultural worlds.

Tools for Life focuses on empowering youth to learn more about their culture and their identity. MISN focuses on helping youth get support from their community and social networks.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Suicide intent/risk
Ramy czasowe: Change from baseline to 3 months

We will use the Suicidal Ideation Attributes Scale (SIDAS) [0 = Never, 10 = Always]

Change from baseline to 3 months
Suicide intent/risk
Ramy czasowe: Change from baseline to 6 months

We will use the Suicidal Ideation Attributes Scale (SIDAS) [0 = Never, 10 = Always]

Change from baseline to 6 months
Suicide intent/risk
Ramy czasowe: Change from baseline to 12 months

We will use the Suicidal Ideation Attributes Scale (SIDAS) [0 = Never, 10 = Always]

Change from baseline to 12 months
Depression
Ramy czasowe: Change from baseline to 3 months

Patient Health Questionnaire (PHQ-9) [0 -not at all to 3-nearly every day]

Change from baseline to 3 months
Depression
Ramy czasowe: Change from baseline to 6 months

Patient Health Questionnaire (PHQ-9) [0 -not at all to 3-nearly every day]

Change from baseline to 6 months
Depression
Ramy czasowe: Change from baseline to 12 months

Patient Health Questionnaire (PHQ-9) [0 -not at all to 3-nearly every day]

Change from baseline to 12 months
Anxiety
Ramy czasowe: Change from baseline to 3 months

Generalized Anxiety Disorder scale (GAD-7) [0 -not at all to 3-nearly every day]

Change from baseline to 3 months
Anxiety
Ramy czasowe: Change from baseline to 6 months

Generalized Anxiety Disorder scale (GAD-7) [0 -not at all to 3-nearly every day]

Change from baseline to 6 months
Anxiety
Ramy czasowe: Change from baseline to 12 months

Generalized Anxiety Disorder scale (GAD-7) [0 -not at all to 3-nearly every day]

Change from baseline to 12 months
Frequency of alcohol use
Ramy czasowe: Change from baseline to 3 months

Number of days used in the past 30 days. [ 0 to 30]

Change from baseline to 3 months
Frequency of alcohol use
Ramy czasowe: Change from baseline to 6 months

Number of days used in the past 30 days [ 0 to 30]

Change from baseline to 6 months
Frequency of alcohol use
Ramy czasowe: Change from baseline to 12 months

Number of days used in the past 30 days [ 0 to 30]

Change from baseline to 12 months
Alcohol use consequences
Ramy czasowe: Change from baseline to 3 months

Number of times in the past 3 months youth experience 4 different alcohol consequences [0 = Never to 6 = 20 or more times]

Change from baseline to 3 months
Alcohol use consequences
Ramy czasowe: Change from baseline to 6 months

Number of times in the past 3 months youth experience 4 different alcohol consequences [0 = Never to 6 = 20 or more times]

Change from baseline to 6 months
Alcohol use consequences
Ramy czasowe: Change from baseline to 12 months

Number of times in the past 3 months youth experience 4 different alcohol consequences [0 = Never to 6 = 20 or more times]

Change from baseline to 12 months

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Sobriety self-efficacy
Ramy czasowe: Change from baseline to 3 months

Three items ask how sure youth are about staying sober from alcohol from 1= def drink to 5 = def not drink

Change from baseline to 3 months
Sobriety self-efficacy
Ramy czasowe: Change from baseline to 6 months

Three items ask how sure youth are about staying sober from alcohol from 1= def drink to 5 = def not drink

Change from baseline to 6 months
Sobriety self-efficacy
Ramy czasowe: Change from baseline to 12 months

Three items ask how sure youth are about staying sober from alcohol from 1= def drink to 5 = def not drink

Change from baseline to 12 months
Intentions to be sober from alcohol
Ramy czasowe: Change from baseline to 3 months

Youth report on intentions to be sober in the next 6 months from 1 = def yes to 4 = def no

Change from baseline to 3 months
Intentions to be sober from alcohol
Ramy czasowe: Change from baseline to 6 months

Youth report on intentions to be sober in the next 6 months from 1 = def yes to 4 = def no

Change from baseline to 6 months
Intentions to be sober from alcohol
Ramy czasowe: Change from baseline to 12 months

Youth report on intentions to be sober in the next 6 months from 1 = def yes to 4 = def no

Change from baseline to 12 months
Social network composition
Ramy czasowe: Change from baseline to 3 months

Participants will be asked to name 15 contacts ("alters") who are at least 18 years of age. Participants will rate each of the 15 people on the same set of questions with categorical response options (about demographics, relationship quality, likelihood to use drugs, etc.). For each participant, the selected responses will be summed across all of the network alters and divided by 15 to produce network composition percentages of the whole set of alters named by the participant (% of AI/ANs, % who engage in heavy drinking).

Change from baseline to 3 months
Social network composition
Ramy czasowe: Change from baseline to 6 months

Participants will be asked to name 15 contacts ("alters") who are at least 18 years of age. Participants will rate each of the 15 people on the same set of questions with categorical response options (about demographics, relationship quality, likelihood to use drugs, etc.). For each participant, the selected responses will be summed across all of the network alters and divided by 15 to produce network composition percentages of the whole set of alters named by the participant (% of AI/ANs, % who engage in heavy drinking).

Change from baseline to 6 months
Social network composition
Ramy czasowe: Change from baseline to 12 months

Participants will be asked to name 15 contacts ("alters") who are at least 18 years of age. Participants will rate each of the 15 people on the same set of questions with categorical response options (about demographics, relationship quality, likelihood to use drugs, etc.). For each participant, the selected responses will be summed across all of the network alters and divided by 15 to produce network composition percentages of the whole set of alters named by the participant (% of AI/ANs, % who engage in heavy drinking).

Change from baseline to 12 months
Social network structure
Ramy czasowe: Change from baseline to 3 months

Participants will rate the relationship strength between each of the 15 named alters. For each alter pair participants will rate if the two people know each other and, if yes, have individuals connected recently. Measures of network structure (i.e., network "connectedness") will be constructed from the set of evaluations for each participant. For example, network "density" will be constructed for the network overall, which is calculated by summing the number of alter pairs who know each other and dividing by the total number of possible ties among 15 alters (105). Individual alter "centrality" will be calculated by summing the number of connections each individual alter has with other alters in the network.

Change from baseline to 3 months
Social network structure
Ramy czasowe: Change from baseline to 6 months

Participants will rate the relationship strength between each of the 15 named alters. For each alter pair participants will rate if the two people know each other and, if yes, have individuals connected recently. Measures of network structure (i.e., network "connectedness") will be constructed from the set of evaluations for each participant. For example, network "density" will be constructed for the network overall, which is calculated by summing the number of alter pairs who know each other and dividing by the total number of possible ties among 15 alters (105). Individual alter "centrality" will be calculated by summing the number of connections each individual alter has with other alters in the network.

Change from baseline to 6 months
Social network structure
Ramy czasowe: Change from baseline to 12 months

Participants will rate the relationship strength between each of the 15 named alters. For each alter pair participants will rate if the two people know each other and, if yes, have individuals connected recently. Measures of network structure (i.e., network "connectedness") will be constructed from the set of evaluations for each participant. For example, network "density" will be constructed for the network overall, which is calculated by summing the number of alter pairs who know each other and dividing by the total number of possible ties among 15 alters (105). Individual alter "centrality" will be calculated by summing the number of connections each individual alter has with other alters in the network.

Change from baseline to 12 months
Time spent around peers who use alcohol
Ramy czasowe: Change from baseline to 3 months

Participants will report on how much time is spent around peers who drink from 0 = never to 3 = often

Change from baseline to 3 months
Time spent around peers who use alcohol
Ramy czasowe: Change from baseline to 6 months

Participants will report on how much time is spent around peers who drink from 0 = never to 3 = often

Change from baseline to 6 months
Time spent around peers who use alcohol
Ramy czasowe: Change from baseline to 12 months

Participants will report on how much time is spent around peers who drink from 0 = never to 3 = often

Change from baseline to 12 months
Awareness of connectedness
Ramy czasowe: Change from baseline to 3 months

Youth report on feelings of connectedness to community, family and environment from 1 = strongly agree to 5 strongly disagree

Change from baseline to 3 months
Awareness of connectedness
Ramy czasowe: Change from baseline to 6 months

Youth report on feelings of connectedness to community, family and environment from 1 = strongly agree to 5 strongly disagree

Change from baseline to 6 months
Awareness of connectedness
Ramy czasowe: Change from baseline to 12 months

Youth report on feelings of connectedness to community, family and environment from 1 = strongly agree to 5 strongly disagree

Change from baseline to 12 months
Community protective factors
Ramy czasowe: Change from baseline to 3 months

Youth Community Protective Factors Scale. Youth report on feelings about different protective factors from 1 = strongly agree to 5 strongly disagree

Change from baseline to 3 months
Community protective factors
Ramy czasowe: Change from baseline to 6 months

Youth Community Protective Factors Scale Youth report on feelings about different community protective factors from 1 = strongly agree to 5 strongly disagree

Change from baseline to 6 months
Community protective factors
Ramy czasowe: Change from baseline to 12 months

Youth Community Protective Factors Scale Youth report on feelings about different community protective factors from 1 = strongly agree to 5 strongly disagree

Change from baseline to 12 months
Individual protective factors
Ramy czasowe: Change from baseline to 3 months

Youth report on feelings about different individual protective factors from 1 = strongly agree to 5 strongly disagree

Change from baseline to 3 months
Individual protective factors
Ramy czasowe: Change from baseline to 6 months

Youth report on feelings about different individual protective factors from 1 = strongly agree to 5 strongly disagree

Change from baseline to 6 months
Individual protective factors
Ramy czasowe: Change from baseline to 12 months

Youth report on feelings about different individual protective factors from 1 = strongly agree to 5 strongly disagree

Change from baseline to 12 months
Reasons for life
Ramy czasowe: Change from baseline to 3 months

Brief Reasons for Life Scale from 1 not at all important to 5 very important

Change from baseline to 3 months
Reasons for life
Ramy czasowe: Change from baseline to 6 months

Brief Reasons for Life Scale from 1 not at all important to 5 very important

Change from baseline to 6 months
Reasons for life
Ramy czasowe: Change from baseline to 12 months

Brief Reasons for Life Scale from 1 not at all important to 5 very important

Change from baseline to 12 months
Reflective processes
Ramy czasowe: Change from baseline to 3 months

The Reflective Processes scale taps a culturally patterned type of awareness and youth report from from 1 = strongly agree to 5 strongly disagree

Change from baseline to 3 months
Reflective processes
Ramy czasowe: Change from baseline to 6 months

The Reflective Processes scale taps a culturally patterned type of awareness and youth report from from 1 = strongly agree to 5 strongly disagree

Change from baseline to 6 months
Reflective processes
Ramy czasowe: Change from baseline to 12 months

The Reflective Processes scale taps a culturally patterned type of awareness and youth report from from 1 = strongly agree to 5 strongly disagree

Change from baseline to 12 months

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Współpracownicy

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

22 grudnia 2022

Zakończenie podstawowe (Rzeczywisty)

31 stycznia 2026

Ukończenie studiów (Rzeczywisty)

31 stycznia 2026

Daty rejestracji na studia

Pierwszy przesłany

29 kwietnia 2022

Pierwszy przesłany, który spełnia kryteria kontroli jakości

29 kwietnia 2022

Pierwszy wysłany (Rzeczywisty)

4 maja 2022

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

27 października 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

22 października 2026

Ostatnia weryfikacja

1 października 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • SP-2020C3-20879

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

The investigators will share only deidentified, aggregate data.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .